EU Regulation 2017/745 (MDR)

The EU’s Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR, which will fully apply from 26 May 2020, is aimed to replace the EU’s current Medical Device Directive 93/42/EEC (MDD) and the EU’s Directive on active implantable medical devices 90/385/EEC (AIMDD). The new regulation is meant to increase reliability, safety and performance to ultimately improve patients’ experience. Two years ago, the European Union embarked upon a 3-year transition period designed to give medical device manufacturers time to comply with new regulatory requirements. Now that the transition period is about to end, a survey of more than 200 regulatory and quality leaders at major medical device Companies showed that 78% of those polled did not have sufficient understanding of the new regulations. This is understandable: the MDR has introduced some key revolution changes in the MedTech field, and there are no “grandfathering” provisions, meaning that medical devices that have been certified under the MDD or under AIMDD, must be re-certified according to the new regulation requirements.

First of all, manufacturers will have to review the updated classification rules and update the technical documentation accordingly. Particularly for class III and implantable medical devices, higher clinical requirements have been introduced. Many medical devices of any risk class now available on the market have been certified with no pre-market product-specific clinical data, and – despite efforts of Companies to collect Post-market Surveillance data – Post Market Clinical Follow-up was based essentially on the update of the pre-market bibliographical clinical evaluation. Now, not only Manufacturers will need to conduct premarket clinical investigations to support product’s claims for safety and performance, but they will have to plan and execute Post Market Clinical Follow-up studies in order to collect clinical data on a dedicated device for certification maintenance.

The more stringent requirements for technical and clinical documentation, requiring much effort in terms of budget and resources, are not the only key changes introduced. There will be the need for a Manufacturer to identify a person responsible for regulatory compliance, and there will be more rigorous scrutiny and surveillance by Notified Bodies. So, the complex development process for medical devices, combined with the changes, make the transition a complicated and time-consuming process for most device Manufacturers.

As a legal manufacturer, in order to meet the obligations set out in the MDR, a Company will need to ensure as a minimum that:

Its medical devices are properly classified (Annex VIII)

General Safety and Performance Requirements (GSPRs) are met (Annex I).

Increased requirements for clinical evidence are met (Annex XIV).

A person responsible for regulatory compliance (PRRC) is in place (Article 15).

Economic operators in the supply chain are compliant.

Vigilance reporting timescales are met and a Periodic Safety Update Report (PSUR), when appropriate, is created (Chapter VII, Section 1 and 2).

MDR action plan

1 Conduct a full portfolio review

In preparing for the MDR, it is important to inform about the requirements and deadlines of the new MDR. Additionally, it is important to perform an assessment of how your current product portfolio may be impacted by the new regulations. Determining the risk class of a medical device is the first essential point of action in specifying the steps required for CE marking. As a manufacturer, you should first check your portfolio of products to determine whether some of your medical devices are to be reclassified and will need to be scrutinized by a Notified Body.

Still not sure on your device’s classification? We can support you! Please feel free to contact us if you need more information.

After a full portfolio review, manufacturers and suppliers should identify gaps in the evidence required for MDR compliance. Gap analysis and a detailed regulatory pathway are extremely important, as a critical step for each Company has to be the assessment of the impact of the MDR on its business, especially for medical devices that lack for sufficient clinical evidence.

We offer gap analysis services and we can help you plan the regulatory and clinical activities needed for MDR compliance. Please feel free to contact us if you need more information.

3 Evaluate if you have a proper system in place to collect clinical data on your “new” or CE-marked device

The MDR has introduced important changes in the medical device development process due to new clinical evidence requirements. Additional clinical evidence will also be required for products already on the market.We can provide you with a proper regulatory and clinical or post-market clinical follow up plan in order to minimize times and costs necessary for MDR compliance.

Please check our clinical services, including clinical studies’ design and management, data management and biostatistics. Don’t forget we are a full service CRO!

Beyond the initial implementation phase, manufacturers will need to establish ongoing compliance activities to support the more stringent requirements around clinical evaluation and quality management. Also, the MDR has introduced important changes in requirements in the post-market phase, including Post Market Surveillance (PMS) planning and implementation, vigilance reporting, PSURs, and the handling field safety corrective actions.

We can help you be compliant! Check our quality, regulatory and clinical services: you will see we can help you through a lot of regulatory and clinical activities, from bench to bed, without forgetting the post-market phase!

Its medical devices are properly classified (Annex VIII)

General Safety and Performance Requirements (GSPRs) are met (Annex I).

Increased requirements for clinical evidence are met (Annex XIV).

A person responsible for regulatory compliance (PRRC) is in place (Article 15).

Economic operators in the supply chain are compliant.

Vigilance reporting timescales are met and a Periodic Safety Update Report (PSUR), when appropriate, is created (Chapter VII, Section 1 and 2).

MDR action plan

1. Conduct a full portfolio review

In preparing for the MDR, it is important to inform about the requirements and deadlines of the new MDR. Additionally, it is important to perform an assessment of how your current product portfolio may be impacted by the new regulations. Determining the risk class of a medical device is the first essential point of action in specifying the steps required for CE marking. As a manufacturer, you should first check your portfolio of products to determine whether some of your medical devices are to be reclassified and will need to be scrutinized by a Notified Body.

Still not sure on your device’s classification? We can support you! Please feel free to contact us if you need more information.

2. Identify all gaps for MDR compliance

After a full portfolio review, manufacturers and suppliers should identify gaps in the evidence required for MDR compliance. Gap analysis and a detailed regulatory pathway are extremely important, as a critical step for each Company has to be the assessment of the impact of the MDR on its business, especially for medical devices that lack for sufficient clinical evidence.

We offer gap analysis services and we can help you plan the regulatory and clinical activities needed for MDR compliance. Please feel free to contact us if you need more information.

3. Evaluate if you have a proper system in place to collect clinical data on your “new” or CE-marked device

The MDR has introduced important changes in the medical device development process due to new clinical evidence requirements. Additional clinical evidence will also be required for products already on the market.We can provide you with a proper regulatory and clinical or post-market clinical follow up plan in order to minimize times and costs necessary for MDR compliance.

Please check our clinical services, including clinical studies’ design and management, data management and biostatistics. Don’t forget we are a full service CRO!

4. Implement and ensure ongoing compliance

Beyond the initial implementation phase, manufacturers will need to establish ongoing compliance activities to support the more stringent requirements around clinical evaluation and quality management. Also, the MDR has introduced important changes in requirements in the post-market phase, including Post Market Surveillance (PMS) planning and implementation, vigilance reporting, PSURs, and the handling field safety corrective actions.

We can help you be compliant! Check our quality, regulatory and clinical services: you will see we can help you through a lot of regulatory and clinical activities, from bench to bed, without forgetting the post-market phase!

Contact Us

Now that the MDR transition period is about to end, we can support you reaching your MDR compliance. We can provide support for most of the regulatory, clinical and quality activities required for MDR and MDD. Interested? Contact us!